A Transparent Surgical Mask to Improve Patient/Caregiver Communication, Minimize Errors and Increase Patient Satisfaction

项目摘要 美国大约有4%的人是聋人或重听人，相当于1300多万人。 其中，大约1200万5岁以上的人难以听到正常的对话 即使在使用助听器时。听力困难影响所有年龄组，并在以下方面提出了重大挑战： 日常生活这些挑战在医疗保健环境中尤其严重，因为沟通不畅会导致 次优治疗，并可能导致严重和潜在危及患者生命的结局。中的错误 人际沟通是导致医疗差错的重要因素， 医护人员和病人戴口罩会增加沟通失误的可能性。外科口罩 是个人防护装备的一个基本项目，防止传染性病原体的传播， 细菌和病毒，但传统的外科口罩可以阻止讲话，防止病人和医疗保健 听力有困难的工人无法读唇。唇阅读是一种重要的视觉辅助手段， 这对每个人来说都很重要，但对聋人或听力有困难的人来说尤为重要。我们的目标是 完成一种可预防传染病的透明外科N95呼吸器面罩的开发 传播和改善医疗保健人员和听力障碍患者之间的沟通。 在第一阶段，我们成功地开发和测试了一种带有透明 一个窗口，使病人和医护人员看到对方的嘴唇，同时保持保护 面具的屏障功能与听力学系的Sam Atcherson博士合作研究， 位于小石城的阿肯色州大学的言语病理学证实了面具作为视觉辅助的有效性，表明， 中度或重度至极重度听力损失的群体受益于来自 面具原型获得专利的FaceView Mask™结合了透明窗口和N95过滤 独特的抗微生物涂层来杀死细菌。在第二阶段，我们建议优化掩模设计， 建立可扩展的生产流程，并进行进一步的测试以支持510（k）批准，NIOSH FaceView Mask™外科N95呼吸器的批准和商业化。具体而言，我们将1）优化 FaceView Mask™，并对最终用户进行调查研究，以确保舒适性和有效的密封 2）与医疗保健专业人员（包括美国标志）进行比较产品测试 语言口译员收集他们对FaceView Mask™与领先的不透明手术N95的看法 呼吸器面罩; 3）执行FaceView Mask™的510（k）许可和NIOSH批准所需的测试; 以及4）在标准实验室测试中以及在卫生保健工作者的使用中测试其抗微生物性能。

PROJECT SUMMARY Approximately 4% of people in the US are either deaf or hard of hearing, equating to more than 13 million people. Of these, approximately 12 million people over the age of 5 years have difficulty hearing normal conversation even when using a hearing aid. Hearing difficulties affect all age groups and present significant challenges in daily life. These challenges are particularly acute in healthcare settings, where miscommunication results in suboptimal treatment and can lead to serious and potentially life-threatening outcomes for patients. Errors in interpersonal communication are an important contributing factor in medical errors, and the wearing of surgical masks by healthcare personnel and patients increases the likelihood of miscommunication. The surgical mask is an essential item of personal protective equipment, preventing the transmission of infectious agents such as bacteria and viruses, but conventional surgical masks can muffle speech and prevent patients and healthcare workers with hearing difficulties from being able to lip read. Lip reading is an important visual aid to communication for everyone but is particularly important for those who are deaf or hard of hearing. Our goal is to complete the development of a transparent surgical N95 respirator mask that prevents infectious disease transmission and improves communication among healthcare personnel and patients with hearing impairment. In Phase I, we successfully developed and tested a prototype surgical N95 respirator mask with a transparent window that enables patients and healthcare workers to see each other’s lips while maintaining the protective barrier function of the mask. A collaborative study with Dr. Sam Atcherson of the Department of Audiology and Speech Pathology at the University of Arkansas at Little Rock validated the mask as a visual aid, showing that groups with either moderate or severe-to-profound hearing loss benefitted from the visual input from the prototype mask. The patented FaceView Mask™ combines the transparent window with both N95 filtration capability and a unique antimicrobial coating to kill bacteria. In Phase II, we propose to optimize the mask design, establish a scalable production process, and conduct further testing to support 510(k) clearance, NIOSH approval, and commercialization of the FaceView Mask™ surgical N95 respirator. Specifically, we will 1) optimize the FaceView Mask™ and conduct a survey study with end users to ensure comfort and an effective seal around the airways; 2) conduct comparative product testing with healthcare professionals, including American Sign Language interpreters to gather their perceptions of the FaceView Mask™ vs. a leading opaque surgical N95 respirator mask; 3) perform testing required for 510(k) clearance and NIOSH approval of the FaceView Mask™; and 4) test its antimicrobial performance both in a standard laboratory test and in use by healthcare workers.